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Suppliers and packagers for ISENTRESS HD
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ISENTRESS HD
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145 | NDA | Merck Sharp & Dohme LLC | 0006-0227-61 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61) | 2007-10-12 |
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145 | NDA | Merck Sharp & Dohme LLC | 0006-3080-01 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-3080-01) | 2017-05-26 |
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145 | NDA | A-S Medication Solutions | 50090-1085-0 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0) | 2007-10-12 |
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145 | NDA | RedPharm Drug, Inc. | 67296-1235-6 | 6 TABLET, FILM COATED in 1 BOTTLE (67296-1235-6) | 2007-10-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ISENTRESS HD
Introduction
ISENTRESS HD (raltegravir extended-release) is an antiretroviral medication used primarily in the treatment of HIV-1 infection. Manufactured by Merck & Co., Inc., ISENTRESS HD is a long-acting formulation designed to improve patient adherence through once-daily dosing. As a significant asset in antiretroviral therapy (ART), understanding its supply chain and the key suppliers involved is vital for stakeholders across healthcare, distribution, and pharmaceutical manufacturing domains.
This article explores the primary suppliers and manufacturing components involved in the production of ISENTRESS HD, analyzing their roles within the supply chain, global manufacturing footprint, and strategic considerations impacting drug availability.
Overview of ISENTRESS HD and Its Composition
ISENTRESS HD contains raltegravir in an extended-release formulation, which modifies drug release kinetics through a polymer matrix. The formulation requires high-quality active pharmaceutical ingredients (APIs), specialized excipients, and precise manufacturing technology. Ensuring a reliable supply of these components is critical for maintaining consistent drug availability worldwide.
Key Suppliers in the Supply Chain
1. Active Pharmaceutical Ingredient (API) Supplier: Merck & Co., Inc.
The chemical synthesis of raltegravir, the active ingredient in ISENTRESS HD, is carried out primarily by Merck itself. Merck’s proprietary manufacturing facilities produce the API at scale to meet global demand and ensure quality compliance under Good Manufacturing Practices (GMP). These facilities are strategically located in the United States and other regions, enabling robust supply management and rapid response to market needs.
2. Excipients and Formulation Components
The extended-release formulation involves various excipients, such as polymers, binders, and fillers that control the drug’s release profile. Key suppliers of these excipients include multinational companies like:
- Evonik Industries: Supplies specialized polymers used in controlled-release matrices.
- Ashland Global Holdings: Provides excipients such as binders and fillers.
- Dow Chemical Company: Offers polymers and other excipient materials integral to sustained-release formulations.
These suppliers often operate global manufacturing sites, ensuring capacity and redundancy across regions.
3. Manufacturer of the Final Drug Product
Merck’s Contract Manufacturing Organizations (CMOs):
Merck contracts with specialized pharmaceutical manufacturing firms to produce ISENTRESS HD’s finished dosage form, including tableting, coating, and packaging. Leading CMOs involved include:
- Baxter BioPharma Solutions: Known for potent-dose solid-dose manufacturing.
- Patheon (a division of Thermo Fisher Scientific): Provides formulation, blending, and tablet pressing capabilities.
The choice of CMOs depends on their capacity, compliance standards, and regional proximity to target markets.
Supply Chain Dynamics and Global Manufacturing Footprint
The manufacturing of ISENTRESS HD benefits from a diversified global supply chain, reducing vulnerability to regional disruptions. Merck's API and formulation components are sourced from multiple suppliers across North America, Europe, and Asia, with manufacturing facilities strategically located to serve North American, European, and emerging markets.
Recent supply chain challenges, including the COVID-19 pandemic, have highlighted the importance of supplier diversification and inventory security. Merck has been investing in expanding manufacturing capacity and improving logistics resilience to sustain steady supply levels.
Regulatory Approvals and Quality Standards
Suppliers involved in producing ISENTRESS HD operate under strict regulatory oversight by agencies such as the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities. Compliance with GMP, quality assurance protocols, and ongoing validation processes are critical to maintaining supply integrity and product efficacy.
Strategic Considerations and Risks
- Supply Concentration Risks: Typically, APIs are sourced from a limited number of suppliers, which heightens risk if any supplier encounters production issues.
- Market-Specific Regulations: Variances in regulatory requirements can influence the selection and qualification of suppliers for different regions.
- Patent and Intellectual Property (IP) Factors: As Merck holds patent rights for raltegravir and its formulations, licensing agreements or patent expirations could impact supplier relationships and manufacturing strategies.
Recent Market Developments
Merck’s commitment to supply security has led to initiatives such as expanding existing facilities, establishing new partnerships with foreign CMOs, and investing in advanced manufacturing technologies. These steps aim to mitigate supply disruptions and meet increasing demand for ISENTRESS HD, especially as HIV treatment guidelines evolve to favor simplified dosing regimens.
Conclusion
The supply for ISENTRESS HD hinges on a finely tuned network of suppliers and manufacturing operations. Merck’s in-house API production remains central, complemented by global excipient suppliers and contract manufacturers for the final dosage forms. Maintaining transparency, capacity, and regulatory compliance across this supply chain is essential for ensuring steady global availability.
As demand grows and markets expand, pharmaceutical companies and healthcare providers must monitor supplier stability, geopolitical influences, and technological advancements that could influence supply continuity.
Key Takeaways
- Main API Source: Merck manufactures raltegravir in its own facilities, underscoring vertical integration for critical components.
- Global Supplier Network: Excipients and formulation components are sourced from top-tier international suppliers like Evonik, Ashland, and Dow.
- Manufacturing Partnerships: Collaboration with CMOs ensures flexible and scalable production, with facilities strategically dispersed worldwide.
- Supply Chain Resilience: Diversification and capacity investments are key strategies in meeting global demand amid geopolitical and pandemic-related challenges.
- Regulatory Compliance: Strict adherence to GMP and quality standards underpins supplier authenticity and product safety.
FAQs
1. Who are the primary suppliers of raltegravir for ISENTRESS HD?
Merck manufactures the active ingredient raltegravir in its own facilities, ensuring quality control and supply security.
2. Are there alternative suppliers for ISENTRESS HD’s ingredients?
Currently, Merck’s API production is vertically integrated. However, excipients are sourced from multiple global suppliers like Evonik and Ashland to mitigate supply risks.
3. How does Merck ensure a stable supply of ISENTRESS HD?
Through capacity expansion, diversification of suppliers, strategic manufacturing partnerships, and adherence to regulatory standards, Merck maintains a resilient supply chain.
4. What challenges could impact the supply of ISENTRESS HD?
Potential challenges include raw material shortages, manufacturing disruptions, regulatory delays, geopolitical issues, and global health crises.
5. Can manufacturers produce generic versions of raltegravir or ISENTRESS HD?
Patent protections currently restrict generic manufacturing of raltegravir. Patent expirations or licensing agreements could open pathways for generic production in the future.
Sources
[1] Merck & Co. Official Website, Product Information on ISENTRESS HD.
[2] U.S. Food and Drug Administration (FDA), Approved Drug Products.
[3] Market research reports on pharmaceutical supply chains and API manufacturing providers.
[4] Industry publications on contract manufacturing organizations (CMOs) and excipient suppliers.
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